The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Mta Material.
| Device ID | K980332 |
| 510k Number | K980332 |
| Device Name: | MTA MATERIAL |
| Classification | Resin, Root Canal Filling |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Contact | P Jeffrey Lehn |
| Correspondent | P Jeffrey Lehn DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-28 |
| Decision Date | 1998-02-24 |
| Summary: | summary |